Due Diligence Solutions fromthoughttofinish
Due Diligence Solutions
ELIQUENT understands the complex regulatory environment within which life sciences transactions take place. ELIQUENT regularly partners with investors to evaluate potential issues and regulatory risks that may be identified during life sciences transactions. Our team of experts provide investors with extensive research, regulatory history assessments, and recommendations on the path forward for potential deals that require regulatory risk analyses before and after decisions and transactions
ELIQUENT’s due diligence services are more than a compilation of public data – we go a step further by enabling the vast institutional knowledge of our regulatory experts to provide in-depth analyses tailored to our clients’ specific needs. ELIQUENT’s multidisciplinary team uses its extensive expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry and regulatory landscape. The result is an unbiased expert analysis of both expected and unexpected regulatory risks
Unlock Success
ELIQUENT’s unique platform goes beyond traditional consulting to deliver full-service support. Our solutions address the entire product lifecycle with best-in-class insight and guidance that bridges the spectrum of regulatory challenges.
From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.
Buy-Side Transactions
Our buy-side due diligence solutions empower investors with comprehensive insights to confidently navigate opportunities and achieve strategic objectives.
Scientific Rigor
With experience across the landscape of therapeutic areas and modalities, the ELIQUENT team provides the technical and scientific expertise investors need when considering a life sciences transaction.
Risk Mitigation
Investing in the life science arena comes with inherent risks. We go beyond identifying risks by providing strategic recommendations to mitigate them effectively, safeguarding your investments.
Market Intelligence
ELIQUENT’s industry knowledge and regulatory expertise offers invaluable market insights, enabling you to anticipate trends, assess competitive landscapes, and capitalize on emerging opportunities.
Sell-Side Transactions
ELIQUENT provides clarity and an objective viewpoint, thereby maximizing value in a transaction, and empowering companies to make informed decisions.
Program Roadmap
ELIQUENT partners with companies to evaluate, prioritize, and optimize commercial assets and programs. By identifying areas for improvement and value enhancement, our team of experts create a roadmap to maximize the prospects for successful regulatory outcomes.
Risk Assessment
Our in-depth assessments go beyond identifying regulatory risks – the ELIQUENT team delivers strategic and technical recommendations for system-wide quality and regulatory enhancements.
Industry Insights
ELIQUENT provides companies with critical insights by monitoring and analyzing the life sciences sector for emerging trends, evolving regulatory reforms, and changes to the competitive landscape.
Unmatched Expertise
Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. With decades of experience in senior positions at the FDA, EMA, and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when working directly with the regulators and when navigating today’s evolving regulatory environment.
Strategic & Technical Capabilities
As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.
Product Development
Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.
Pathway Evaluation
Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.
Regulatory Submissions
Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.
Compliance Status
Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.
Distribution & Supply Chain
Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.
Preclinical & Clinical Systems
Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations.
Reporting Requirements
Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations.
Quality Manufacturing
Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.
Adverse Event Reporting
Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation.
Marketing & Promotion
Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions.
Global Solutions
Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.
United States
ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.
Europe
The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock-step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.
Asia
ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.
Explore ELIQUENT Japan >>
Focus Areas
ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.
Integrated Solutions.
Full-Service Support
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
Regulatory Affairs Solutions
PV+ Postmarket Surveillance
Quality & Compliance
Remediation Solutions
Talent Solutions
From the earliest phases of innovation through regulatory submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.
With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance solutions empower companies to operate with confidence.
Our team of highly specialized quality & compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.
ELIQUENT’s Remediation Solutions address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.
Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.
Your resource for regulatory clarity.
IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.
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